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    NDC 00536-1241-27 Mini Nicotine 4 mg/1 Details

    Mini Nicotine 4 mg/1

    Mini Nicotine is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories, Inc.. The primary component is NICOTINE.

    Product Information

    NDC 00536-1241
    Product ID 0536-1241_e5251669-82d9-4e1e-9018-e76480349971
    Associated GPIs 62100010004720
    GCN Sequence Number 077140
    GCN Sequence Number Description nicotine polacrilex LOZNG MINI 4 MG BUCCAL
    HIC3 J3A
    HIC3 Description SMOKING DETERRENT AGENTS (GANGLIONIC STIM,OTHERS)
    GCN 43056
    HICL Sequence Number 002049
    HICL Sequence Number Description NICOTINE POLACRILEX
    Brand/Generic Generic
    Proprietary Name Mini Nicotine
    Proprietary Name Suffix n/a
    Non-Proprietary Name Nicotine Polacrilex
    Product Type HUMAN OTC DRUG
    Dosage Form LOZENGE
    Route ORAL
    Active Ingredient Strength 4
    Active Ingredient Units mg/1
    Substance Name NICOTINE
    Labeler Name Rugby Laboratories, Inc.
    Pharmaceutical Class Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA207868
    Listing Certified Through 2025-12-31

    Package

    NDC 00536-1241-27 (00536124127)

    NDC Package Code 0536-1241-27
    Billing NDC 00536124127
    Package 1 BOTTLE, PLASTIC in 1 BOX (0536-1241-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC
    Marketing Start Date 2019-07-31
    NDC Exclude Flag N
    Pricing Information N/A